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Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/187338/2014 

Last updated

About this guideline

Overseas effective date: 1 November 2016

Categories: Biologicals | Active substance | Manufacture, characterisation and control of the active substance.

TGA annotations: Nil

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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  • Important Note: Refer to TGA position statement regarding mRNA technology

 For more information see International scientific guidelines adopted in Australia.

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